small molecule

ZORYVE

ROFLUMILAST

Loss of exclusivityAugust 2042latest FDA-listed patent expiry
CompanyArcutis Biotherapeutics, Inc.See this company's full patent-cliff portfolio

Drug detail

Brand nameZORYVE
Active ingredientROFLUMILAST
Strength0.3%
Dosage formFOAM
RouteTOPICAL
ModalitySmall molecule
FDA approvalDecember 2023
Marketing statusRX

Listed patents

PatentExpiresType
12453721August 2042product
12329751December 2041use U-3773
11707454December 2041use U-3773
11129818August 2037use U-3773
12310956June 2037use U-4203
12011437June 2037product
12016848June 2037product
12005052June 2037product
12257242June 2037product
12336983June 2037product
12220409June 2037product
12042487June 2037product
9884050June 2037product
10940142June 2037product
11793796June 2037product
9907788June 2037use U-3773
12390453June 2037product
11819496June 2037use U-3773
11992480June 2037use U-3773
12005051June 2037use U-3773

Regulatory exclusivity

CodeExpires
I-969May 2028
NPDecember 2026

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

ZORYVE patent cliff — loss of exclusivity August 2042 | CliffBio